MAUDE manufacturer profile

COOPERSURGICAL, INC. · HEW

MAUDE profile for Culdoscope (And Accessories)

Key facts

Manufacturer COOPERSURGICAL, INC.
Manufacturer group COOPERSURGICAL, INC.
Product code HEW
Product code name Culdoscope (And Accessories)

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Break, Insufficient Information, Detachment of Device or Device Component, Melted, Adverse Event Without Identified Device or Use Problem, Laceration(s) Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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